Label: BANANA BOAT LIGHT AS AIR FACE SUNSCREEN UVA UVB BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 63354-548-22
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 30, 2019
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- Active Ingredient
- Purpose
- Uses
- Warnings
- May stain
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Directions
Apply liberally 15 minutes before sun exposure • Reapply: after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts,pants, hats, and sunglasses
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Inactive Ingredients
Water, Diisopropyl Adipate, Silica, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexlyglycerin, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Disodium EDTA, Fragrance, Polymethylsilsesquioxane, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Panthenol, Aloe Barbadensis Leaf Juice
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INGREDIENTS AND APPEARANCE
BANANA BOAT LIGHT AS AIR FACE SUNSCREEN UVA UVB BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-548 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLORPHENESIN (UNII: I670DAL4SZ) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) COCO GLUCOSIDE (UNII: ICS790225B) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ALOE VERA LEAF (UNII: ZY81Z83H0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) STARCH, TAPIOCA (UNII: 24SC3U704I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-548-22 88 g in 1 TUBE; Type 0: Not a Combination Product 05/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/30/2019 Labeler - Edgewell Personal Care Brands LLC (151179769)
